Screening-level Hazard Characterization Sponsored Chemical 1-decene Tetramer Mixed With 1-decene Trimer Hydrogenated (CASRN 68649-12-7)

U.S Environmental Protection Agency
Hazard Characterization Document

September, 2010

SCREENING-LEVEL HAZARD CHARACTERIZATION
SPONSORED CHEMICAL

1-Decene, Tetramer, Mixed with 1-decene Trimer, Hydrogenated

(CASRN 68649-12-7)

SUPPORTING CHEMICALS
(See Section 1)

The High Production Volume (HPV) Challenge Program1 was conceived as a voluntary initiative
aimed at developing and making publicly available screening-level health and environmental
effects information on chemicals manufactured in or imported into the United States in quantities
greater than one million pounds per year. In the Challenge Program, producers and importers of
HPV chemicals voluntarily sponsored chemicals; sponsorship entailed the identification and
initial assessment of the adequacy of existing toxicity data/information, conducting new testing if
adequate data did not exist, and making both new and existing data and information available to
the public. Each complete data submission contains data on 18 internationally agreed to "SIDS"
(Screening Information Data Set1'2) endpoints that are screening-level indicators of potential
hazards (toxicity) for humans or the environment.

The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is
evaluating the data submitted in the HPV Challenge Program on approximately 1400 sponsored
chemicals by developing hazard characterizations (HCs). These HCs consist of an evaluation of
the quality and completeness of the data set provided in the Challenge Program submissions.

They are not intended to be definitive statements regarding the possibility of unreasonable risk of
injury to health or the environment.

The evaluation is performed according to established EPA guidance2'3 and is based primarily on
hazard data provided by sponsors; however, in preparing the hazard characterization, EPA
considered its own comments and public comments on the original submission as well as the
sponsor's responses to comments and revisions made to the submission. In order to determine
whether any new hazard information was developed since the time of the HPV submission, a
search of the following databases was made from one year prior to the date of the HPV
Challenge submission to the present: (ChemID to locate available data sources including
Medline/PubMed, Toxline, HSDB, IRIS, NTP, AT SDR, IARC, EXTOXNET, EPA SRS, etc.),
STN/CAS online databases (Registry file for locators, ChemAbs for toxicology data, RTECS,
Merck, etc.) and Science Direct. OPPT's focus on these specific sources is based on their being
of high quality, highly relevant to hazard characterization, and publicly available.

OPPT does not develop HCs for those HPV chemicals which have already been assessed
internationally through the HPV program of the Organization for Economic Cooperation and

1 U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm.

2 U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm.

3 U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm.

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Development (OECD) and for which Screening Initial Data Set (SIDS) Initial Assessment
Reports (SIAR) and SIDS Initial Assessment Profiles (SIAP) are available. These documents are
presented in an international forum that involves review and endorsement by governmental
authorities around the world. OPPT is an active participant in these meetings and accepts these
documents as reliable screening-level hazard assessments.

These hazard characterizations are technical documents intended to inform subsequent decisions
and actions by OPPT. Accordingly, the documents are not written with the goal of informing the
general public. However, they do provide a vehicle for public access to a concise assessment of
the raw technical data on HPV chemicals and provide information previously not readily
available to the public.

2

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Sponsored Chemical

1-Decene, tetramer, mixed with 1-decene trimer,
hydrogenated

Chemical Abstract Index
Name

Supporting Chemicals

1-Decene, homopolymer, hydrogenated
1-Dodecene, polymer with 1-decene, hydrogenated
1-Dodecene, polymer with 1-decene and 1-octene,
hydrogenated
1-Dodecene trimer, hydrogenated

Structural Formula

See Section 1

Summary

CASRN 68649-12-7 is a clear, colorless liquid mixture with low vapor pressure and negligible
water solubility. It is expected to have low mobility in soil. Volatilization of CASRN
68649-12-7 is considered high based on its Henry's Law constant; however, adsorption to
suspended solids and sediment is expected to attenuate the rate of volatilization. The rate of
hydrolysis is considered negligible due to the lack of hydrolyzable functional groups. The rate of
atmospheric photooxidation is considered moderate. CASRN 68649-12-7 is expected to have
low persistence (PI) and low bioaccumulation potential (Bl).

No data are available for the sponsored substance. Acute oral, inhalation and dermal toxicities of
the supporting chemicals, CASRN 151006-60-9 and CASRN 151006-62-1 are low in rats.

Acute oral toxicity of the supporting chemical, CASRN 163149-28-8, and acute inhalation
toxicity of the supporting chemical, CASRN 68037-01-4, are low in rats. Repeated oral
exposure to the supporting chemical, CASRN 68037-01-4, to rats for periods of 4 weeks

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(gavage) or 90 days (dietary and gavage administration), showed no significant systemic effects.
The NOAEL for systemic toxicity is 5000 mg/kg-day (4-week) and 1000 mg/kg-day (90-day)
(highest dose tested). Repeated oral exposure to the supporting chemical, CASRN 151006-62-1,
for 28 days, showed no significant treatment-related effects in rats. The NOAEL for systemic
toxicity is 1000 mg/kg-day (highest dose tested). Repeated dermal exposures of the supporting
chemical, CASRN 163149-28-8, for 4 weeks, showed no significant effects in rats up to 2000
mg/kg-day; the NOAEL for systemic toxicity is 2000 mg/kg-day (highest dose tested). In a
combined oral repeated-dose/reproductive toxicity study in rats with the supporting chemical
CASRN 68037-01-4, no reproductive toxicity was observed up to 1000 mg/kg-day; the NOAEL
for reproductive toxicity is 1000 mg/kg-day. In a dermal prenatal developmental toxicity study
in rats with the supporting chemical, CASRN 68037-01-4, no treatment-related effects were
observed up to 2000 mg/kg-day. The NOAEL for maternal and developmental toxicity is 2000
mg/kg-day (highest dose tested). Available data for the supporting chemicals indicate negative
results for genotoxicity. The supporting chemicals, CASRNs 151006-60-9, 163149-28-8 and
151006-62-1, were negative for gene mutations in bacteria in vitro. The supporting chemicals,
CASRNs 163149-28-8 and 151006-62-1, were negative for chromosomal aberrations in
mammalian cells in vitro. The supporting chemicals, CASRN 68037-01-4, CASRN 151006-60-
9 and CASRN 151006-62-1, were negative for the induction of micronuclei in vivo.

No data are available for the sponsored substance. However, the low water solubility and high
Log Kow of CASRN 68649-12-7 is not expected to have any toxic effects on aquatic organisms.

No data gaps were identified under the HPV Challenge Program.

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The sponsor, the American Chemistry Council Higher Olefins Panel, submitted a Test Plan and
Robust Summaries to EPA for 1-decene, tetramer, mixed with 1-decene trimer, hydrogenated
(CASRN 68649-12-7; CA Index name: 1-decene, tetramer, mixed with 1-decene trimer,
hydrogenated) on December 20, 2001. EPA posted the submission on the ChemRTK HPV
Challenge website on January 29, 2002

(http://www.epa.gov/chemrtk/pubs/summaries/ldectmix/cl3433tc.htm). EPA comments on the
original submission were posted to the website on September 9, 2002. Public comments were
also received and posted to the website. The sponsor submitted updated/revised documents on
October 4, 2002, which were posted to the ChemRTK website on February 5, 2008.

Justification for Supporting Chemicals

The sponsored substance (1-decene, tetramer, mixed with 1-decene trimer, hydrogenated,
CASRN 68649-12-7) is a long chain branched alkane (a hydrogenated polyalphaoleftn). In
addition to data on the sponsored substance, the sponsor provided data for four closely related
supporting chemicals, including 1-decene homopolymer, hydrogenated (decene homopolymer)
(CASRN 68037-01-4); 1-decene/1-dodecene copolymer, hydrogenated (decene/dodecene
copolymer) (CASRN 151006-60-9); 1-octene, 1-decene, 1-dodecene copolymer, hydrogenated
(octene/decene/dodecene copolymer) (CASRN 163149-28-8) and 1-dodecene trimer,
hydrogenated (dodecene trimer) (CASRN 151006-62-1). Each supporting chemical contains
long-chain branched alkanes, derived from C8, C10 and/or C12 alpha olefins. Based on similar
molecular structures and comparable toxicological effects data, EPA agrees with the use of data
for these supporting chemicals to address the data gaps for the sponsored substance.

1. Chemical Identity

1.1 Identification and Purity

The test plan states that decene tetramer/trimer is a long chain branched alkane (a hydrogenated
polyalphaolefin). The predominant (-85%) and shortest oligomers present is a C30 chain, with a
C40 oligomer comprising most of the remainder.

The chemical structures are summarized in Table 1.

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Table 1: Sponsored and Supporting Chemical Structures

Chemical Abstract Index Name

CASRN

Structure

Sponsored Chemical

1-Decene, tetramer, mixed with
1-decene trimer, hydrogenated

68649-12-7

ch3 ch3
(ch3

ch3

Representative trimer structure1

Supporting Chemicals

1-Decene homopolymers,
hydrogenated

68037-01-4

n is unknown

1-Dodecene, polymer with
1-decene, hydrogenated

151006-60-9

n and m are unknown

1-Dodecene, polymer with
1-decene and 1-octene,
hydrogenated

163149-28-8

n, m and p are unknown

6

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Table 1: Sponsored and Supporting Chemical Structures

Chemical Abstract Index Name

CASRN

Structure

1-Dodecene trimer, hydrogenated

151006-62-1

-3c3E

1 1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated is a mixture of long chain branched alkanes
prepared from hydrogenated oligomers of 1-decene (a hydrogenated polyalphaolefin [PAO]). The predominant and
shortest oligomer present is a C30 trimer (-85%) with a C40 tetramer (-13%) and decene pentamers and higher
(-2%) representing the remainder of the mixture. The representative structure used for 1-decene, tetramer, mixed
with 1-decene trimer, hydrogenated indicates the oligomerization reaction of 1-decene occurs at the beta position
leaving secondary methyl groups. The SMILES notation used by the sponsor for estimation indicates the presence
of 3 olefin bonds which is incorrect given the substance is hydrogenated. The sponsor does not provide a structure
for the test substance elsewhere in the submitted documents.

1.2 Physical-Chemical Properties

The physical-chemical properties of 1-decene, tetramer, mixed with 1-decene trimer,
hydrogenated are summarized in Table 2.

1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated is a clear, colorless liquid mixture
with a negligible water solubility and low vapor pressure.

Table 2. Physical-Chemical Properties of 1-Decene, tetramer, mixed with 1-decene trimer,
hydrogenated 1

Property

Value

CASRN

68649-12-7

Molecular Weight

422.81

Physical State

Liquid, clear and colorless2

Melting Point

a

-73°C (measured, pour point)

Boiling Point

>316°C (measured)1'3;
414°C(measured)2

Vapor Pressure

<0.1 mmHg at 20°C (measured);
1.7 mmHg at 177°C (measured)2

Water Solubility

<0.1 parts per trillion (measured)5;
< 1.0xl0"10mg/L at25°C (estimated)4

Dissociation Constant (pKa)

Not applicable

Henry's Law Constant

1.5 x 103 atm-mVmole (estimated)4

Log Kow

>7.0 (measured)5;
14.82 (estimated)4

7

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Table 2. Physical-Chemical Properties of 1-Decene, tetramer, mixed with 1-decene trimer,
hydrogenated 1

Property

Value

1 American Chemistry Council Higher Olefins Panel October 4, 2002. Revised Robust Summary and Test Plan for
1-Decene, Tetramer, Mixed with 1-Decene Trimer Hydrogenated. Available online from:
http://www.epa.gov/chemrtk/pubs/summaries/ldectmix/cl3433tc.htm as of May 20, 2010.

2 Chevron Phillips Chemicals, Material Safety Data Sheet, Synfluid ® 4 cStPAO, CASRN 68649-12-7, Available
online from: http://www.dowpol.com/UploadFiles/200861Q112842998.pdf as of May 25, 2010.

3 The measured data submitted by the sponsor was generated using a test substance composed of decene trimers
(85%), tetramers (13%), and pentamers and highr (2%).

4U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental
Protection Agency, Washington, DC, USA. Available online from:
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of May 20, 2010.

5 Sponsor cites as read across value for an analogous chemical, 1-dodecene trimer, hydrogenated (CASRN 151006-
62-1)

2. General Information on Exposure

2.1 Production Volume and Exposure

CASRN 68649-12-7 had an aggregated production and/or import volume in the United States
between 50 and 100 million pounds during calendar year 2005.

Industrial processing and use information as well as commercial and consumer use information
of the chemical are claimed confidential in the 2006 IUR.

2.2 Environmental Exposure and Fate

The environmental fate properties of 1-decene, tetramer, mixed with 1-decene trimer,
hydrogenated are summarized in Table 3.

1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated is expected to have low mobility
in soil. 1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated was found not readily
biodegradable using EPA Shake Flask Method (EPA 560/6-82-003, CG-2000) with
unacclimated sewage/soil inoculum. Activated sludge was used as the inoculum at a
concentration of 30 mg/L. Test substance concentrations of 10 and 20 mg/L were found to
biodegrade 54% and 49% respectively after 28 days. Although these data do not meet the
criteria to be considered readily biodegradable, the data show that 1-decene, tetramer, mixed
with 1-decene trimer, hydrogenated can biodegrade to an appreciable extent, which suggests that
it will not persist in the environment. The rate of hydrolysis is considered negligible due to the
lack of hydrolysable functional groups present in the representative structure. The potential for
volatilization is considered high based on its Henry's Law constant; however, adsorption to
suspended solids and sediment is expected to attenuate the rate at which this substance
volatilizes. 1-Decene, tetramer, mixed with 1-decene trimer, hydrogenated is expected to have
low persistence (PI) and low bioaccumulation potential (Bl).

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Table 3. Environmental Fate Characteristics of 1-Decene, tetramer, mixed with 1-decene

trimer, hydrogenated



Property

Value

Photodegradation Half-life

3.6 hours (estimated)2

Hydrolysis Half-life

Stable

Biodegradation

49-54% degradation after 28 days (not readily biodegradable)

Bioaccumulation Factor

BAF = 6.2(estimated)2

Log Koc

8.2 (estimated)2

Fugacity

(Level III Model)2

Air (%)

2.0

Water (%)

45.8

Soil (%)

52.1

Sediment (%)

<0.1

Persistence3

PI (low)

•>

Bioaccumulation

Bl(low)

1 American Chemistry Council Higher Olefins Panel October 4, 2002. Revised Robust Summary and Test Plan for
1-Decene, Tetramer, Mixed with 1-Decene Trimer, Hydrogenated. Available online from:
http://www.epa.gov/chemrtk/pubs/summaries/ldectmix/cl3433tc.htm as of May 20, 2010.

2U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental
Protection Agency, Washington, DC, USA. Available online from:
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of May 25, 2010.

3 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal
Register 64, Number 213 (November 4, 1999) pp. 60194-60204.

Conclusion: CASRN 68649-12-7 is a clear, colorless liquid mixture with low vapor pressure
and negligible water solubility. It is expected to have low mobility in soil. Volatilization of
CASRN 68649-12-7 is considered high based on its Henry's Law constant; however, adsorption
to suspended solids and sediment is expected to attenuate the rate of volatilization. The rate of
hydrolysis is considered negligible due to the lack of hydrolyzable functional groups. The rate of
atmospheric photooxidation is considered moderate. CASRN 68649-12-7 is expected to have
low persistence (PI) and low bioaccumulation potential (Bl).

3. Human Health Hazard

No health effects data were submitted for the sponsored substance. A summary of health effects
data submitted for SIDS endpoints is provided in Table 4.

Acute Oral Toxicity

1-Decene/l-dodecene copolymer, hydrogenated (CASRN 151006-60-9, supporting chemical)

Sprague-Dawley rats (5/sex/dose) were administered 1-decene/l-dodecene copolymer,
hydrogenated via gavage at 5000 mg/kg-bw and observed for 14 days. There were no
mortalities.

LD50 > 5000 mg/kg-bw

9

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1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN163149-28-8, supporting
chemical)

Sprague-Dawley rats (5/sex/dose) were administered 1-octene, 1-decene, 1-dodecene copolymer,
hydrogenated via gavage at 2000 mg/kg-bw and observed for 14 days. There were no
mortalities.

LD50 > 2000 mg/kg-bw

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

Sprague-Dawley rats (5/sex/dose) were administered 1-dodecene trimer, hydrogenated via
gavage at 5000 mg/kg-bw and observed for 14 days. There were no mortalities.

LD50 > 5000 mg/kg-bw

Acute Dermal Toxicity

1-Decene/l-dodecene copolymer, hydrogenated (CASRN 151006-60-9, supporting chemical)

Sprague-Dawley rats (5/sex/dose) were administered 1-decene/1-dodecene copolymer,
hydrogenated via the dermal route at 2000 mg/kg-bw under semi-occlusive conditions for 24
hours and observed for 14 days. There were no mortalities.

LD50 > 2000 mg/kg-bw

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

Sprague-Dawley rats (5/sex/dose) were administered 1-dodecene trimer, hydrogenated via the
dermal route at 2000 mg/kg-bw under semi-occlusive conditions for 24 hours and observed 14
days. There were no mortalities.

LD50 > 2000 mg/kg-bw

Acute Inhalation Toxicity

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

Sprague-Dawley rats (10/sex/concentration) were exposed to 1-decene homopolymer,
hydrogenated at mean aerosol (mass median aerodynamic diameter of 1.1 |im) concentrations of
0, 0.48 or 2.5 mg/L for 4 hours. Half of the animals in each group were sacrificed the day after
exposure and necropsied; the remaining animals were observed for 14 days and then sacrificed.
There were no mortalities.

LC50 > 2.5 mg/L

1-Decene/l-dodecene copolymer, hydrogenated (CASRN 151006-60-9, supporting chemical)

Sprague-Dawley rats (5/sex/concentration) were exposed (nose-only) to 1-decene/1-dodecene
copolymer, hydrogenated at an aerosol (mass median aerodynamic diameter of 1.3 |im) at a
single concentration of 5.0 mg/L for 4 hours and observed for 14 days. There were no
mortalities.

LC50 > 5.0 mg/L

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

Sprague-Dawley rats (5/sex/concentration) were exposed (nose-only) to 1-dodecene trimer,
hydrogenated at an aerosol (mass median aerodynamic diameter of 1.2 |im) concentration of

10

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5.06 mg/L for 4 hours and observed for 14 days. There were no mortalities.

LC50 > 5.06 mg/L

Repeated-Dose Toxicity

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

(1) In a 4-week range-finding study, female Sprague-Dawley rats (5/dose) were administered 1-
decene homopolymer, hydrogenated via gavage at 0, 500, 2500 or 5000 mg/kg-day, 5 days/week.
No deaths occurred and no changes in body weight were observed. The only clinical signs that
could be attributed treatment were oily staining around the anus and soft stool. No gross
pathological changes were observed in any group. Histological evaluations of the liver revealed
no adverse effects.

NOAEL = 5000 mg/kg-day (highest dose tested)

(2) In a 90-day study, Sprague-Dawley rats (20/sex/dose) were administered 1-decene
homopolymer, hydrogenated via the diet at 0, 500, 5000 or 20,000 ppm (~ 0, 25, 250 and 1000
mg/kg-day). No mortality or clinical signs indicative of toxicity were observed. 1-Decene
homopolymer, hydrogenated did not adversely affect body weight gain, food consumption,
urinalysis, ophthalmology or hematology. A linear relationship was found between dose and
serum level for albumin/globulin ratio in males and between dose and inorganic phosphorus
level in females, which was considered statistically significant. The biological significance of
this finding is not clear. There were no changes in organ weights and no changes on the enteric
tract were observed. None of the major organs or major organ systems, including male and
female reproductive organs, showed any treatment-related changes.

NOAEL ~ 1000 mg/kg-day (highest dose tested)

(3) In a 90-day study, Fischer 344 rats (10/sex/dose) were administered 1-decene homopolymer,
hydrogenated via the diet at 0, 200 or 20,000 ppm (~ 0, 10 or 1000 mg/kg-day). Aside from two
animals that died during the 13-week blood collection, all animals survived until the end of the
study. No clinical signs or changes in food consumption, body weight gain, ophthalmology or
hematology were observed. Statistically significant differences in the serum chemistry data
(glucose in males and sodium, phosphorus and calcium in females) were observed with treatment
(level of significance not stated). The differences were considered marginal and the biological
significance was unclear. There were no treatment-related changes in the liver or mesenteric
lymph nodes.

NOAEL ~ 1000 mg/kg-day (highest dose tested)

(4) In a combined repeated-dose/reproductive toxicity screening test, Sprague-Dawley rats
(30/sex/dose for F0 and 20/sex/dose for Fl) were administered 1-decene homopolymer,
hydrogenated in polyethylene glycol 400 via gavage at 0, 100, 500 or 1000 mg/kg-day, 7
days/week. F0 males were dosed for 4 weeks prior to mating and through the 15-day mating
period and F0 females were dosed from 4 weeks prior to mating, through pregnancy and until
day 20 post-partum. Offspring were dosed for 91 days starting on day 22 post-partum. No
treatment-related toxicity was observed in the F0 rats. The Fl pups did not demonstrate any
treatment-related toxicity during parturition and lactation. In the Fl rats during the 91-day
toxicity phase, clinical observations representing minor gastrointestinal disturbances were seen

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in all groups and were judged to be vehicle-related. No treatment-related clinical observations
were noted. A significant increase in prothrombin time was seen in high-dose males; however,
this change did not correlate with a decrease in platelets, gross necropsy findings or any
histopathological lesions. There was no evidence of any adverse effects on clinical observations,
organ weights, gross toxicity or histopathology, clinical chemistry or hematology endpoints.
NOAEL = 1000 mg/kg-day (highest dose tested)

1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN163149-28-8, supporting
chemical)

In a 4-week study, Sprague-Dawley rats (10/sex/dose) were administered 1-octene, 1-decene, 1-
dodecene copolymer, hydrogenated via the dermal route at 0, 125, 500 or 2000 mg/kg-day, under
unocclusive conditions 5 days/week. Two additional groups, one control and one high-dose,
were included and allowed a 2-week recovery period. No dermal irritation was observed at
exposure sites. There were no effects on food consumption during the study. During the fourth
week of the study, male rats had significantly decreased body weight, higher neutrophil counts
(level of significance not stated) and changes in 7 of 20 serum chemistry parameters (satellite
group only). Following the recovery period, no changes in hematological parameters were
observed in control or treated animals: females showed statistical differences between controls
and treated animals for two serum chemistry parameters. No macroscopic findings were noted at
necropsy in the treated groups or groups allowed recovery periods. Microscopic changes were
limited to the skin, which showed an increased incidence of hyperplasia and hyperkeratosis in
treated and control animals.

NOAEL = 2000 mg/kg-day (highest dose tested)

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

In a 28-day study, Sprague-Dawley rats (5/sex/dose) were administered 1-dodecene trimer,
hydrogenated via gavage at 0 or 1000 mg/kg-day for 28 days. Two additional groups, one
control and one high-dose, were included and allowed a 2-week recovery period following the
dosing period. There were no deaths, clinical signs of toxicity or effects on body weight, food
consumption, water consumption, hematology, blood chemistry or organ weights. No treatment-
related effects were observed at necropsy and no histopathological effects were observed.
NOAEL = 1000 mg/kg-day (highest dose tested)

Reproductive Toxicity

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

In the combined repeated-dose/reproductive toxicity screening test previously described, there
were no treatment-related effects on any of the reproductive parameters evaluated, including
reproductive performance (mating, conception and fertility, time to mating, gestation length,
litter size), offspring survival (gestation and postnatal survival indices, percent pre- and post-
implantation loss), pup body weight and pup sex ratio. No treatment-related effects on
reproductive organ weight or histopathology were seen in the 91-day toxicity study with F1
animals.

NOAEL (reproductive toxicity) = 1000 mg/kg-day (highest dose tested)

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Developmental Toxicity

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

Pregnant Sprague-Dawley rats (15/dose) were administered 1-decene homopolymer,
hydrogenated via the dermal route at 0, 800 or 2000 mg/kg-day on gestation days 0-19. Rats in
the treatment groups showed minimal, if any, irritation at the site of application. There were no
treatment-related effects on food consumption during gestation. There was a significant
(significance not stated) smaller weight gain during gestation days 13 - 16 at 2000 mg/kg-day;
however, the overall weight gain during gestation was not significantly different between
controls and treated animals. Serum triglycerides and albumin showed significant (significance
not stated) changes between control and treated groups; the significance of which is not clear. At
necropsy, there were no findings attributable to exposure. Reproductive performance, in utero
survival and development of the offspring were not affected by treatment. Individual body
weights and crown-rump lengths of the fetuses were not altered by treatment. External, visceral
and skeletal examinations of the fetuses did not reveal any remarkable findings.

NOAEL (maternal and developmental toxicity) = 2000 mg/kg-day (highest dose tested)

Genetic Toxicity - Gene mutation

In vitro

1-Decene/l-dodecene copolymer, hydrogenated (CASRN 151006-60-9, supporting chemical)

In a reverse-mutation assay, Salmonella typhimurium strains TA1535, TA1537, TA98 and
TA100 and Escherichia coli strain WP2mrA- were exposed to 1-decene/l-dodecene copolymer,
hydrogenated in 25% w/w Pluronic F127 in ethanol at 0, 15, 50, 150, 500, 1500 or 5000 |ig/plate
in the presence or absence of metabolic activation. Vehicle, negative and positive controls were
tested concurrently and responded appropriately. The cytotoxic concentration was > 5000
|ig/plate. 1-Decene/l-dodecene copolymer, hydrogenated did not induce increased frequency of
revertant colonies either with or without metabolic activation.

CASRN 151006-60-9 was not mutagenic in this assay.

1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN 163149-28-8, supporting
chemical)

In a reverse-mutation assay, Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98
and TA100 were exposed to 1-octene, 1-decene, 1-dodecene copolymer, hydrogenated at 0.1,
0.3, 1.0, 3.0 or 10.0 |iL/50 |iL tetrahydrofuran (THF) vehicle per plate in the presence or absence
of metabolic activation. Vehicle and positive controls were tested concurrently and responded
appropriately. Cytotoxicity was not observed. None of the strains exhibited reversion
frequencies that were substantially different from spontaneous or solvent controls in two
independent assays.

CASRN 163149-28-8 was not mutagenic in this assay.

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

(1) Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli
strain WP2wvrA- were exposed to 1-dodecene trimer, hydrogenated in 25% w/w Pluronic F127
in ethanol at 0, 15, 50, 150, 500, 1500 or 5000 |ig/plate in the presence and absence of metabolic
activation. Vehicle, negative and positive controls were tested concurrently and responded

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September, 2010

appropriately. Precipitation occurred at or above 1500 |ig/plate. The cytotoxic concentration
was greater than 5000 |ig/plate. No increase in the frequency of revertent colonies was recorded
for any of the bacterial strains tested at any concentration of the test substance with or without
metabolic activation.

CASRN 151006-62-1 was not mutagenic in this assay.

(2) Chinese hamster ovary (CHO) cells were exposed to 1-dodecene trimer, hydrogenated in
ethanol, at 313, 625, 1250, 2500 or 5000 |ig/mL for 4 hours in the presence or absence of
metabolic activation. The cytotoxic concentration was greater than 5000 |ig/mL. Positive and
vehicle controls were conducted concurrently and responded appropriately. A significant
increase in mutant frequency was observed at 625 and 2500 |ag/m L with activation, but was not
dose-dependent and was within historical control range.

CASRN 151006-62-1 was not mutagenic in this assay.

Genetic Toxicity - Chromosomal aberrations

In vitro

1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN 163149-28-8, supporting
chemical)

CHO cells were exposed to 1-octene, 1-decene, 1-dodecene copolymer, hydrogenated in
tetrahydrofuran (THF) at 0.1, 0.2 or 0.4 |iL/mL in the presence or absence of metabolic
activation. Cells were exposed to 1-octene, 1-decene, 1-dodecene copolymer, hydrogenated for
2 hours in the presence of metabolic activation and harvested after 16 hours. Cells that were not
exposed to metabolic activation were continually exposed to 1-octene, 1-decene, 1-dodecene
copolymer, hydrogenated in THF until cell harvest. A confirmatory test was conducted with
delayed (40-hour) harvest. No increase in the proportion of cells with chromosomal aberrations
was observed compared to controls. Positive and vehicle controls were tested concurrently and
responded appropriately.

CASRN 163149-28-8 did not induce chromosomal aberrations in this assay.

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

Human lymphocytes were exposed to 1-dodecene trimer, hydrogenated in ethanol at 39, 78.1,
156.25, 312.5, 625, 1250, 2500 or 5000 |ig/mL in the presence or absence of metabolic
activation. Cultures with metabolic activation were treated for 4 hours and harvested after 16
additional hours. Cultures without activation were exposed continuously for 20 hours. In a
confirmatory experiment, cultures with activation were exposed for 4 hours and harvested 16 and
40 hours later. Positive and vehicle controls were conducted concurrently and responded
appropriately. 1-Dodecene trimer, hydrogenated did not induce increased frequency of
chromosomal aberrations in any of the tests either with or without metabolic activation.

CASRN 151006-62-1 did not induce chromosomal aberrations in this assay.

In vivo

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

Rats (15/sex/dose; strain not specified) were administered 1-decene homopolymer, hydrogenated
via the dermal route at 0, 800 or 2000 mg/kg-day, 5 days/week for 13 weeks. At the end of the
13-week period, tissues were harvested for micronucleus evaluation. Femurs were taken from

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Hazard Characterization Document

September, 2010

five rats/sex/dose and peripheral blood smears were made. 1-Decene homopolymer,
hydrogenated was not cytotoxic to red blood cell formation. 1-Decene homopolymer,
hydrogenated did not induce increases in micronucleated polychromatic or normochromatic
erythrocytes at either dose level.

CASRN 68037-01-4 did not induce formation of micronuclei in this assay.

1-Decene/l-dodecene copolymer, hydrogenated (CASRN 151006-60-9, supporting chemical)
CD-I mice (5/sex/dose) were administered 1-decene/l-dodecene copolymer, hydrogenated (in
arachis oil vehicle) via the intraperitoneal route at 1250, 2500 or 5000 mg/kg-bw and sacrificed
at 24, 48 and 72 hours after dosing. There were no premature deaths or clinical signs of toxicity
observed at any dose level. Positive and vehicle controls were tested concurrently and responded
appropriately. A significant increase in the frequency of micronucleated polychromatic
erythrocytes was recorded in the 5000 mg/kg dose group sacrificed at 24 hours; however, this
increase was within the range of historical controls. 1-Decene/l-dodecene copolymer,
hydrogenated did not increase the frequency of micronucleated polychromatic erythrocytes.
CASRN 151006-60-9 did not induce formation of micronuclei in this assay.

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

CD-I mice (5/sex/dose) were administered 1-dodecene trimer, hydrogenated (in arachis oil
vehicle) via the intraperitoneal route at 1250, 2500 or 5000 mg/kg-bw and sacrificed at 24, 48
and 72 hours after dosing. No premature deaths or clinical signs of toxicity were observed at any
dose. Positive and vehicle controls were tested concurrently and responded appropriately. A
significant increase in the frequency of micronuclei occurred in the 24-hour 5000 mg/kg-bw test
group, but this value was within the range of historical controls and therefore not considered to
be dose-related.

CASRN 151006-62-1 did not induce formation of micronuclei in this assay.

Additional Information

Carcinogenicity

1-Decene homopolymer, hydrogenated (CASRN 68037-01-4, supporting chemical)

Male C3H mice (50/group) were administered 1-decene homopolymer, hydrogenated via the
dermal route at a dose of 50 |iL/appli cation to the interscapular skin twice weekly for 104 weeks.
Negative and positive controls were tested concurrently. No treatment-related tumors were seen.
In the negative control group, no primary skin tumors developed. The summary indicated that
changes in the skin were minimal and nonspecific. Some hyperplasia was observed and deemed
to be due to repeated hair removal. In the positive controls, 47 of 50 mice developed skin
tumors. Survival in the treated group (56%) was higher than in the control group (42%). In the
treated group, skin changes were similar to the negative controls.

CASRN 68037-01-4 did not increase the incidence of tumors in this study.

Conclusion: No data are available for the sponsored substance. Acute oral, inhalation and
dermal toxicities of the supporting chemicals, CASRN 151006-60-9 and CASRN 151006-62-1
are low in rats. Acute oral toxicity of the supporting chemical, CASRN 163149-28-8, and acute
inhalation toxicity of the supporting chemical, CASRN 68037-01-4, are low in rats. Repeated

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September, 2010

oral exposure to the supporting chemical, CASRN 68037-01-4, to rats for periods of 4 weeks
(gavage) or 90 days (dietary and gavage administration), showed no significant systemic effects.
The NOAEL for systemic toxicity is 5000 mg/kg-day (4-week) and 1000 mg/kg-day (90-day)
(highest dose tested). Repeated oral exposure to the supporting chemical, CASRN 151006-62-1,
for 28 days, showed no significant treatment-related effects in rats. The NOAEL for systemic
toxicity is 1000 mg/kg-day (highest dose tested). Repeated dermal exposures of the supporting
chemical, CASRN 163149-28-8, for 4 weeks, showed no significant effects in rats up to 2000
mg/kg-day; the NOAEL for systemic toxicity is 2000 mg/kg-day (highest dose tested). In a
combined oral repeated-dose/reproductive toxicity study in rats with the supporting chemical
CASRN 68037-01-4, no reproductive toxicity was observed up to 1000 mg/kg-day; the NOAEL
for reproductive toxicity is 1000 mg/kg-day. In a dermal prenatal developmental toxicity study
in rats with the supporting chemical, CASRN 68037-01-4, no treatment-related effects were
observed up to 2000 mg/kg-day. The NOAEL for maternal and developmental toxicity is 2000
mg/kg-day (highest dose tested). Available data for the supporting chemicals indicate negative
results for genotoxicity. The supporting chemicals, CASRNs 151006-60-9, 163149-28-8 and
151006-62-1, were negative for gene mutations in bacteria in vitro. The supporting chemicals,
CASRNs 163149-28-8 and 151006-62-1, were negative for chromosomal aberrations in
mammalian cells in vitro. The supporting chemicals, CASRN 68037-01-4, CASRN 151006-60-
9 and CASRN 151006-62-1, were negative for the induction of micronuclei in vivo.

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Hazard Characterization Document

September, 2010

Table 4. Summary Table of the Screening Information Data Set
as submitted under the U.S. HPV Challenge Program - Human Health Data

Endpoints

SPONSORED
CHEMICAL
Decene, tetramer,
mixed with 1
decene trimer,
hydrogenated
(68649-12-7)

SUPPORTING
CHEMICAL

1-Decene
homopolymer,
hydrogenated

(68037-01-4)

SUPPORTING
CHEMICAL
1-Decene/l-
dodecene
copolymer,
hydrogenated
(151006-60-9)

SUPPORTING
CHEMICAL
1-Octene, 1-decene,
1-dodecene
copolymer,
hydrogenated
(163149-28-8)

SUPPORTING
CHEMICAL
1-Dodecene
trimer,
hydrogenated

(151006-62-1)

Acute Oral Toxicity
LD50 (mg/kg-bw)

No Data
>2000
(RA)



>5000

>2000

>5000

Acute Dermal Toxicity
LD5o (mg/kg-bw)

No Data
>2000
(RA)



>2000



>2000

Acute Inhalation Toxicity
LC50 (mg/L)

No Data
>2.5
(RA)

>2.5

>5.0

*

>5.06

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U.S Environmental Protection Agency
Hazard Characterization Document

September, 2010

Table 4. Summary Table of the Screening Information Data Set
as submitted under the U.S. HPV Challenge Program - Human Health Data

Endpoints

SPONSORED
CHEMICAL
Decene, tetramer,
mixed with 1
decene trimer,
hydrogenated
(68649-12-7)

SUPPORTING
CHEMICAL

1-Decene
homopolymer,
hydrogenated

(68037-01-4)

SUPPORTING
CHEMICAL
1-Decene/l-
dodecene
copolymer,
hydrogenated
(151006-60-9)

SUPPORTING
CHEMICAL
1-Octene, 1-decene,
1-dodecene
copolymer,
hydrogenated
(163149-28-8)

SUPPORTING
CHEMICAL
1-Dodecene
trimer,
hydrogenated

(151006-62-1)

Repeated-Dose Toxicity
NOAEL/LOAEL
Rat Oral (mg/kg-day)

No Data
NOAEL= 1000
(RA)

(28-day gavage)
NOAEL = 5000
(highest dose
tested)

(90-day gavage)
NOAEL = 1000
(highest dose
tested)

(90-day diet)
NOAEL ~ 1000
(highest dose
tested)





(28-day gavage)
NOAEL = 1000
(highest dose
tested)

Repeated-Dose Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)

No Data
NOAEL = 2000
(RA)

-

-

(28-day)
NOAEL = 2000
(highest dose
tested)

-

Reproductive Toxicity
Oral (mg/kg-day)

Reproductive and Systemic
Toxicity

No Data
NOAEL = 1000
(RA)

NOAEL = 1000
(highest dose
tested)

-

-

-

18

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U.S Environmental Protection Agency
Hazard Characterization Document

September, 2010

Table 4. Summary Table of the Screening Information Data Set
as submitted under the U.S. HPV Challenge Program - Human Health Data

Endpoints

SPONSORED
CHEMICAL
Decene, tetramer,
mixed with 1
decene trimer,
hydrogenated
(68649-12-7)

SUPPORTING
CHEMICAL

1-Decene
homopolymer,
hydrogenated

(68037-01-4)

SUPPORTING
CHEMICAL
1-Decene/l-
dodecene
copolymer,
hydrogenated
(151006-60-9)

SUPPORTING
CHEMICAL
1-Octene, 1-decene,
1-dodecene
copolymer,
hydrogenated
(163149-28-8)

SUPPORTING
CHEMICAL
1-Dodecene
trimer,
hydrogenated

(151006-62-1)

Developmental Toxicity
Dermal (mg/kg-day)

Developmental and Maternal

Toxicity

No Data
NOAEL = 2000
(RA)

NOAEL = 2000
(highest dose
tested)

-

-

-

Genetic Toxicity - Gene

Mutation

In vitro

No Data
Negative
(RA)

-

Negative

Negative

Negative

Genetic Toxicity -
Chromosomal Aberrations
In vitro

No Data
Negative
(RA)

-

-

Negative

Negative

Genetic Toxicity -
Chromosomal Aberrations
In vivo

No Data
Negative
(RA)

Negative

Negative



Negative

Additional Information
Carcinogenicity

-

Negative
(male mice)

-

-

-

Measured data in bold text; - indicates that endpoint was not addressed for this chemical; (RA) = read across

19

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4. Hazard to the Environment

No data were submitted for the sponsor substance, 1-decene, tetramer, mixed with 1-decene
trimer, hydrogenated. A summary of aquatic toxicity data submitted for SIDS endpoints is
provided in Table 5.

Acute Toxicity to Fish

1-Dodecene trimer, hydrogenated (CASRN151006-62-1, supporting chemical)

Rainbow trout (Oncorhynchus mykiss) were exposed to 1-dodecene trimer, hydrogenated as
water accommodated fractions (WAFs) under semi-static conditions for 96 hours. In a range-
finding study, no mortalities were observed at loading rates of 100 or 1000 mg/L. In the
definitive study, the loading rate was 1000 mg/L and total organic carbon (TOC) analysis of the
WAF showed no significant levels of carbon compared to controls. No effects were noted at the
1000 mg/L loading rate.

No effects at saturation.

Acute Toxicity to Aquatic Invertebrates

1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN 163149-28-8, supporting
chemical)

Water fleas (Daphnia magna) were exposed to 1-octene, 1-decene, 1-dodecene copolymer,
hydrogenated as WAFs under static conditions for 48 hours. The loading rates were of 0, 360,
630, 1350, 2610 or 5220 mg/L and analytical measurements were below the limit of quantitation
(2 mg/L). No effects were noted at any of the WAF loading rates.

No effects at saturation.

1-Dodecene trimer, hydrogenated (CASRN 151006-62-1, supporting chemical)

Water fleas (Daphnia magna) were exposed to 1-dodecene trimer, hydrogenated as WAFs under
static conditions for 48 hours. In a range-finding study, no mortalities were observed at loading
rates of 100 or 1000 mg/L. In the definitive study, the loading rate was 1000 mg/L and TOC
analysis of the WAF showed no significant levels of carbon compared to the controls. No effects
were noted at the 1000 mg/L loading rate
No effects at saturation.

Toxicity to Aquatic Plants

1-Octene, 1-decene, 1-dodecene copolymer, hydrogenated (CASRN 163149-28-8, supporting
chemical)

Green algae (Pseudokirchneriella subcapitata) were exposed to 1-octene, 1-decene, 1-dodecene
copolymer, hydrogenated as WAFs under static conditions for 72 hours. The loading rates were
0, 360, 630, 1350, 2610 or 5220 mg/L and mean measured concentrations were below the limit
of quantitation (2 mg/L). No effects were noted at any of the WAF loading rates and a
stimulatory response was seen at > 630 mg/L.

No effects at saturation.

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September, 2010

Conclusion: No data are available for the sponsored substance. However, the low water
solubility and high Log Kow CASRN 68649-12-7 is not expected to have any toxic effects on
aquatic organisms.

Table 5. Summary Table of the Screening Information Data Set
as submitted under the U.S. HPV Challenge Program - Aquatic Toxicity Data

Endpoints

SPONSORED
CHEMICAL
Dcccnc, tctramcr, mixed
with 1 dcccnc trimcr,
hydrogenated
(68649-12-7)

SUPPORTING
CHEMICAL
1-Octene, 1-decene,
1-dodecene copolymer,
hydrogenated
(163149-28-8)

SUPPORTING
CHEMICAL
1-Dodecene trimer,
hydrogenated

(151006-62-1)

Fish

96-h LCso (mg/L)

No Data
NES
(RA)

-

NES

Aquatic
Invertebrates
48-h ECso (mg/L)

No Data
NES
(RA)

NES

NES

Aquatic Plants
72-h ECso (mg/L)
(growth)
(biomass)

No Data
NES
NES
(RA)

NES

-

- indicates that endpoint was not addressed for this chemical; (RA) = read across; NES = no effects at saturation

21

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